The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery

Condition(s) targeted: Post-operative Pain; Colon Cancer; Diverticulitis

Intervention: Bupivacaine (Drug); Bupivacaine liposome suspension (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Des Moines University

Official(s) and/or principal investigator(s):
Rachel Knudson, DO, Principal Investigator, Affiliation: Mercy Medical Center

The purpose of the study is to evaluate the effect of Exparel on pain control and patient outcome after colon resection. The investigators will evaluate the clinical course of the patients who receive exparel as compared to the patients who do not receive exparel. Exparel is a 72 hour bupivacaine which is slowly released from lysosomes over the course of three days. A long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3. 5 hour half-life.

Official title: The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Primary outcome: PCA (patient controlled analgesia) usage

Secondary outcome:

Oral Pain Medications

Total IV (intravenous) narcotic used

Total Oral narcotic used

Length of Stay

return of bowel function

Readmission

Toradol Use

Ofirmev

Nausea Medication

Foley catheter removal

Postoperative pain

Post operative Satisfaction

Home oral narcotic use

Detailed description: Patients who are undergoing elective colon resection with Dr. Kraemer and Dr. Raman will be offered participation in the study. This will include robotic, laparoscopic and open procedures. In the pre-operative area prior to surgery, the surgical resident will inform the patient of the opportunity to participate in the research study. The resident will consent the patient at that time, if the patient chooses to participate, they will be randomized to an exparel or non-exparel group. The randomization will be done by having the resident pick an envelope that will state whether or not the patient is randomized to the exparel or non-exparel group, this will randomize to 50% in each group. The patient will not be notified of the type of local anesthetic they receive. The attending surgeon will also be blind to the type of local the pt will receive; only the resident and Operating Room (OR) staff will know what type of local anesthetic was given. Unfortunately the opaque color of the exparel precludes the physician injecting the local anesthetic from being blinded to the type of anesthetic given. The patient will be taken to the operating room as usual, and the surgery will proceed as it normally would. At the end of the surgery the patient will receive either exparel or bupivacaine depending upon which the patient was randomized to. The attending surgeon will not be in the operating suite while the local anesthetic is being injected. 30 milliliters (mL) of either exparel or bupivacaine will be injected into the subcutaneous tissues at the end of surgery. The patient will be taken to the post operative care unit (PACU), the medications for post-operative pain will be standardized between the two groups, a standard starting dose on the patient controlled analgesia (PCA) will be used, and will be adjusted as needed. The postoperative care will attempt to be standardized in regard to diet, discharge (dc) of foley, not using nasogastric (NG) tubes, however this will be based on the individual patient was what is best for their care. This data will then be analyzed to determine if exparel has a beneficial effect on surgical care.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Elective colon resection for both benign and malignant disease

- Laparoscopic, robotic and open techniques

Exclusion Criteria:

- emergent colon cases

- cases preformed by surgeons other than Dr. Raman or Dr. Kraemer

- pregnant patients

- patients currently breast feeding

- patients under the age of 18

- other patients unable to give informed consent

- bupivacaine use within 96 hours

- allergy to amide anesthetics

- prisoners

- caution will be used in patients with renal or hepatic failure.

Mercy Medical Center, Des Moines, Iowa 50314, United States

Starting date: February 2013
Last updated: January 30, 2014